NCT04444895

A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).

Detailed description

This study consists of 26-week treatment period (Day 0 to Day 182) and a 2-week follow-up period. Participants who completed the double-blind treatment period at Day 182 of Study SHP643-303 (NCT04206605) will enroll into this extension study.

Conditions

• Angioedema

Interventions

Type	Name	Description
DRUG	Lanadelumab	Lanadelumab SC injection

Timeline

• Start date: 2021-02-05
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2020-06-24
• Last updated: 2024-06-17
• Results posted: 2024-06-17

Locations

35 sites across 10 countries: United States, Canada, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study